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Clinical Trial

NORM-HF Pivotal Study

NCT: NCT07574593 · NOT_YET_RECRUITING

NCT IDNCT07574593
StatusNOT_YET_RECRUITING
Start Date2026-05
Completion2033-12

Brief Summary

This is an international, multi-center, prospective, randomized, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF patients is superior for reducing the combined endpoint of worsening HF events and cardiovascular mortality compared to standard of care treatment. Patients will be randomized in a 1:1 ratio to receive either NORM™ System and guided heart failure management (intervention group) or usual standard of care with guided heart failure management (control group).

Frequently Asked Questions

What is NORM-HF Pivotal Study?

NORM-HF Pivotal Study is a clinical trial registered under NCT07574593. Current status: NOT_YET_RECRUITING.

What is the status of NCT07574593?

The current status of NCT07574593 (NORM-HF Pivotal Study) is: NOT_YET_RECRUITING.

When did NORM-HF Pivotal Study start?

NORM-HF Pivotal Study started on 2026-05.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.